Q4 and FY 2020 Results - Press Conference January 26, 2021 - Novartis
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Disclaimer This presentation contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995, that can generally be identified by words such as “potential,” “expected,” “will,” “planned,” “pipeline,” “outlook,” or similar expressions, or by express or implied discussions regarding potential new products, potential new indications for existing products, potential product launches, or regarding potential future revenues from any such products; or regarding the impact of the COVID-19 pandemic on certain therapeutic areas including dermatology, ophthalmology and the Sandoz retail business, and on drug development operations; or regarding potential future, pending or announced transactions; regarding potential future sales or earnings of the Group or any of its divisions; or by discussions of strategy, plans, expectations or intentions; or regarding the Group’s liquidity or cash flow positions and its ability to meet its ongoing financial obligations and operational needs; or regarding our not-for-profit portfolio of 15 medicines from the Sandoz division for symptomatic treatment of COVID-19 and our collaboration with Molecular Partners to develop, manufacture and commercialize potential medicines for the prevention and treatment of COVID-19. Such forward-looking statements are based on the current beliefs and expectations of management regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. You should not place undue reliance on these statements. In particular, our expectations could be affected by, among other things: liquidity or cash flow disruptions affecting our ability to meet our ongoing financial obligations and to support our ongoing business activities; the impact of the COVID-19 pandemic on enrollment in, initiation and completion of our clinical trials in the future, and research and development timelines; the impact of a partial or complete failure of the return to normal global healthcare systems including prescription dynamics by mid 2021; global trends toward healthcare cost containment, including ongoing government, payer and general public pricing and reimbursement pressures and requirements for increased pricing transparency; uncertainties regarding potential significant breaches of data security or data privacy, or disruptions of our information technology systems; regulatory actions or delays or government regulation generally, including potential regulatory actions or delays with respect to the development of the products described in this presentation; the potential that the strategic benefits, synergies or opportunities expected from the transactions described, including BeiGene, may not be realized or may be more difficult or take longer to realize than expected; the uncertainties in the research and development of new healthcare products, including clinical trial results and additional analysis of existing clinical data; our ability to obtain or maintain proprietary intellectual property protection, including the ultimate extent of the impact on Novartis of the loss of patent protection and exclusivity on key products; safety, quality, data integrity, or manufacturing issues; uncertainties involved in the development or adoption of potentially transformational technologies and business models; uncertainties regarding actual or potential legal proceedings, investigations or disputes; our performance on environmental, social and governance measures; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases such as COVID-19; uncertainties regarding future global exchange rates; uncertainties regarding future demand for our products; and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this presentation as of this date and does not undertake any obligation to update any forward-looking statements as a result of new information, future events or otherwise. Enbrel® is a registered trademark of Amgen, Inc. Humira® and Skyrizi™ are registered trademarks of Abbvie Inc. Siliq® is a registered trademark Valeant Pharmaceuticals International, Inc. Taltz® is a registered trademark of Eli Lilly and Company. Stelara®, Tremfya® and Simponi® are registered trademarks of Janssen Biotech, Inc. Cimzia® is a registered trademark of UCB Group of Companies. 2 Novartis Q4 and FY 2020 Results | January 26, 2021 | Novartis Media Presentation
Participants Vas Narasimhan Susanne Schaffert Chief Executive Officer President, Novartis Oncology Harry Kirsch Richard Saynor Chief Financial Officer CEO, Sandoz Marie-France Tschudin Shannon Thyme Klinger President, Novartis Pharmaceuticals Chief Legal Officer 3 Novartis Q4 and FY 2020 Results | January 26, 2021 | Novartis Media Presentation
Vas Narasimhan Chief Executive Officer 4 Novartis Q4 and FY 2020 Results | January 26, 2021 | Novartis Media Presentation
We are transforming Novartis... Strategy set out in 2018... ...is transforming Novartis Our focus Our five priorities 100% focused as a medicines company Focus our Unleash the Deliver company power of our transformative and capital people innovation Leading pipeline, with 4 advanced therapy platforms Achieved USD 2bn cost savings over 2017-2020 Accelerate Embrace Go big certain operational on data geographies excellence and digital Establishing a leading digital and data science platform Improving ESG scores, sector-leading across 4 key indices Strengthen Build trust our core with society Record-high engagement score 5 Novartis Q4 and FY 2020 Results | January 26, 2021 | Novartis Media Presentation
...while delivering strong operational performance Innovative Medicines Net sales +5% CAGR1 Core3 OpInc +10% CAGR1 Continuing operations2, USD bn core3 margin up to 35% 2017 2018 2019 2020 2017 2018 2019 2020 2017 2018 2019 2020 48.7 35.0% 47.4 15.4 14.1 33.5% 44.8 12.6 32.0% 42.3 31.0% 11.7 1. CAGR % 2017-20 in USD 2. Refers to continuing operations as defined on page 43 of the Condensed Financial Report, excludes Alcon, includes the businesses of Innovative Medicines and Sandoz, as well as the continuing corporate functions 3. Constant currencies (cc) and core results are non-IFRS measures. An explanation of non-IFRS measures can be found on page 55 of the Condensed Financial Report 6 Novartis Q4 and FY 2020 Results | January 26, 2021 | Novartis Media Presentation
Q4 sales growth and margin expansion driven by strong performance from key growth drivers Operational performance Key growth driver sales Q4 2020 Key growth drivers and launches, Growth Continuing operations1, % cc vs. PY Sales Growth vs. PY vs. PY as % of Innovative Medicines sales USD mn USD mn cc 716 35% Adakveo® 198 52% Beovu® Q4 2020 FY 2020 1,109 13% 144 Mayzent® 471 23% 43% Piqray® Net 3% 91 sales Xiidra® 376 83 24% Lutathera® 1% 254 68 33% 34% Kymriah® Kisqali® 240 62 32% 28% Ilaris® 408 52 13% Zolgensma® Core2 13% 141 45 42% Jakavi® OpInc Tafinlar+Mekinist® 57 40 nm Promacta® 34 33 nm Entresto® Cosentyx® 335 32 8% Q4 Q4 Q4 Q4 2017 2018 2019 2020 Other3 2% 184 29 18% 3. Includes Tasigna®, Xolair®, Aimovig®, Tabrecta ®, Kesimpta®, nm – not meaningful Luxturna® , Enerzair ® and Atectura® 1. Refers to continuing operations as defined on page 43 of the Condensed Financial Report, excludes Alcon, includes the businesses of Innovative Medicines and Sandoz, as well as the continuing corporate functions 2. Core results are non-IFRS measures. An explanation of non-IFRS measures can be found on page 55 of the Condensed Financial Report 7 Novartis Q4 and FY 2020 Results | January 26, 2021 | Novartis Media Presentation
Sandoz sales met guidance with significant margin growth, despite pandemic impact Sales stable, core margin Key 2020 performance drivers Driving growth increased by +3.3%pts in 2020 (vs. PY, in cc) Biopharmaceuticals1 growth Biosimilars +19%, increasing share in 15+ pipeline assets, many entering clinical maturing European markets phase soon Q4 2020 FY 2020 Sales of up to USD 3.5bn expected by 2025 Retail decline Net sales driven by COVID-19 and US Small molecules 0% oral solids High LoE coverage (EU: >80%, US: >50%) 0% with approximately 40 US first-to-files until Margin increase from 2024 product mix, productivity, Core OpInc favorable price effects; 15% reduced spend Driving margin (mid-to-high 20s in mid-to long term) 3% Manufacturing optimization Product mix from higher biosimilar share Operational excellence including use of digital Core 20.8% 24.2% margin: +3.3%pts 1. Biopharmaceuticals include biosimilars, biopharmaceutical contract manufacturing and Glatopa ® 8 Novartis Q4 and FY 2020 Results | January 26, 2021 | Novartis Media Presentation
Novartis focused on overcoming COVID-19 challenges Select examples Dermatology market declines with COVID-19 Key areas impacted in 2020 expected to PsO market weekly patient visits Jan-Aug 2020 PsO market weekly NBRx Jan-Aug 2020 4.0 continue through H1 2021 25 20 3.0 Dynamic segment of Several therapeutic areas, Visit Volum e (thousands) Thousands 15 2.0 market (new/switch particularly dermatology and 10 patients): less patient ophthalmology 1.0 5 traffic, less F2F New launches 0 0.0 physician access Jan Mar May Aug Oct Dec Jan Mar May Aug Oct Dec (e.g. Kesimpta®, Mayzent®) Sources: IQVIA Visits Data. IQVIA National Prescription Audit for Dermatology Advanced breast cancer (CDK4/6 market and Piqray®) Oncology market declines with COVID-19 Biopsy and surgery rates CDK4/6 market NBRx 120 Hospital initiation (lab Kymriah® -20% work, diagnostics); 100 Lutathera® 80 immuno-suppression 60 concerns Zolgensma® 40 20 Breast Lung Melanoma Lower demand Sandoz Retail 0 Pre- Mar COVID Apr May Jun Jul Aug Sep Oct Pre-COVID baseline Q3’19-Q1’20 Avg. Sep’20-Nov’20 Avg. and anti-infectives Source: IQVIA APLD, Novartis Analysis Source: IQVIA projection 9 Novartis Q4 and FY 2020 Results | January 26, 2021 | Novartis Media Presentation
Made significant strides in building trust with society and in integrating ESG across every aspect of our company Key ESG developments over the past 12 months and selected aspirations Ethical Pricing Global Health Corporate Governance & Standards & Access Challenges Citizenship Transparency Resolved material legacy Introduced 100+ Expanded our Africa sickle Strong COVID-19 response ESG index launched compliance issues Emerging Market Brands cell disease program Integrating D&I efforts Reporting in line with TCFD Launched Code of Ethics Issued sustainability- Advancing pipeline of across our operations Working towards integrated linked bond novel malaria treatments reporting Select 200% increase in SITs 50% increase in our Full carbon, plastic and ESG targets embedded into commitments patient reach by 2025 1 Flagship Programs’ reach water neutrality by 2030 executive remuneration by 20251 Significant improvements recognized by third party ESG rating agencies SIT – Strategic innovative therapies 1. As defined in ESG bond prospectus More details in Novartis in Society Report: www.novartis.com/nisreport2020 10 Novartis Q4 and FY 2020 Results | January 26, 2021 | Novartis Media Presentation
Harry Kirsch Chief Financial Officer 11 Novartis Q4 and FY 2020 Results | January 26, 2021 | Novartis Media Presentation
2020 financial results in line with guidance As revised in Q3 investor call Group full year guidance FY 2020 vs. PY In cc in cc “Sales expected to grow mid single digit assuming return to normal prescription dynamics. 3% 3 to 4% range in case of resurgence of COVID-19” “Core operating income to grow low double digit to mid teens” 13% 12 Novartis Q4 and FY 2020 Results | January 26, 2021 | Novartis Media Presentation
Solid FY performance on top and bottom line Continuing operations 1 Q4 Change vs. PY FY Change vs. PY USD million 2020 % USD % cc 2 2020 % USD % cc 2 Net Sales 12,770 3 1 48,659 3 3 2 Core Operating income 3,501 1 2 15,416 9 13 Operating income 2,644 45 51 10,152 12 19 Net Income 2,099 86 93 8,071 13 20 2 Core EPS (USD) 1.34 2 3 5.78 9 13 EPS (USD) 0.92 84 93 3.55 14 21 2 Free Cash Flow 3,342 -4 11,691 -10 1. Refers to continuing operations as defined on page 43 of the Condensed Financial Report, excludes Alcon, includes the busi nesses of Innovative Medicines and Sandoz, as well as the continuing corporate functions 2. Constant currencies (cc), core results and free cash flow are non-IFRS measures. An explanation of non-IFRS measures can be found on page 55 of the Condensed Financial Report 13 Novartis Q4 and FY 2020 Results | January 26, 2021 | Novartis Media Presentation
Novartis proposes 24th consecutive dividend increase to the AGM: 3.00 CHF / share1 2020 dividend yield 3.6%2 2020 dividend growth 1.7%3 3.5 USD 3.404 3.0 USD 3.12 CHF dividend USD dividend CHF 3.00 CHF 2.95 2.5 2.0 1.5 1.0 0.5 0.0 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 1. Proposal to shareholders at the 2021 Annual General Meeting, taking place on March 2, 2021 2. Based on closing share p rice of CHF 83.65 at end of business year 2020 (December 30, 2020) 3. In CHF 4. Converted at historic exchange rates at the dividend payment dates as per Bloomberg for 2020, assumes an exchange rate of USD/CHF of 0.88106 as of December 31, 2020 14 Novartis Q4 and FY 2020 Results | January 26, 2021 | Novartis Media Presentation
2021 Novartis full year guidance Barring unforeseen events; growth vs. PY in cc Continuing operations | full year guidance1 vs. PY (cc) Sales expected to grow low to mid single digit IM Division expected to grow mid single digit Sandoz expected to be broadly in line with prior year Core operating income expected to grow mid single digit, ahead of sales 1. Key assumptions: Our guidance assumes that we see a return to normal global healthcare systems including prescription dynamics by mid 2021 In addition, we assume that no Gilenya and no Sandostatin LAR generics enter in 2021 in the US 15 Novartis Q4 and FY 2020 Results | January 26, 2021 | Novartis Media Presentation
Vas Narasimhan Chief Executive Officer 16 Novartis Q4 and FY 2020 Results | January 26, 2021 | Novartis Media Presentation
2021 catalysts maintaining long-term momentum Potential catalysts Selected examples Major approvals Kesimpta® (EU/JP) Entresto® (US) Cosentyx® (US/JP/CN) RMS HFpEF Pediatric psoriasis Major submissions1 Alpelisib (BYL719) Asciminib (ABL001) Jakavi® PROS CML Acute and chronic GvHD Beovu® Leqvio® (US)2 Kymriah® DME Hyperlipidemia FL 177Lu-PSMA-617 Sabatolimab (MBG453) Canakinumab (ACZ885)3 Major readouts mCRPC MDS NSCLC 1L + 2L Enabling submission 2021 Kymriah® Entresto® r/r DLBCL 1st relapse Post-AMI Ligelizumab (QGE031)4 Cosentyx® Enabling submission 2022 CSU HS Iptacopan (LNP023) Kisqali® Others IgAN, C3G (Ph2) Breast cancer (MONALEESA-2 OS) Pivotal study starts Iptacopan (LNP023) Ligelizumab (QGE031) 177Lu-PSMA-617 IgAN, C3G, aHUS Food allergy, CINDU pre-taxane 1. First submission in any market. 2. Novartis received a CRL from the FDA due to unresolved facility inspection-related conditions at a third-party manufacturing facility in Europe. FDA has not raised any concerns related to the efficacy or safety of inclisiran. Response to CRL planned to be submitted Q2 - Q3 2021. 3. Depending on timing of final read-out submission may move to early 2022 4. Q4/2021-Q1/2022 potential COVID impact 17 Novartis Q4 and FY 2020 Results | January 26, 2021 | Novartis Media Presentation
Moving forward a breadth of assets to drive long-term growth Selected opportunities: selection of expected 2021 milestones and additional indications Lifecycle management Pharmaceuticals Oncology Post-AMI: PARADISE Iptacopan IgAN, C3G: Ph2 readout H1 2021 Canakinumab NSCLC 1L/2L: CANOPY-1/2 Ph3 readout H1 2021 (LNP023) (ACZ885) Ph3 readout H1/2 2021 Entresto® aHUS: Ph3 start. PNH, iMN HFpEF: FDA action date Q1 2021 NSCLC adjuvant Iscalimab 177 Lu-PSMA-617 mCRPC 3L: HS: SUNRISE, SUNSHINE Sjögren's, kidney Tx, liver Tx (CFZ533) VISION Ph3 readout H1 2021 Ph3 readout H2 2021 Cosentyx® L. Planus, Peds PsO, jPsA/ER, Ligelizumab CSU: PEARL 1, 2 mCRPC pre-taxane: GCA, lupus nephritis (QGE031) Ph3 readout H2 2021 Ph3 start H1 2021 aBC: MONALEESA-2 OS CINDU, food allergy Sabatolimab HR-MDS: STIMULUS Kisqali® readout H2 2021 (MBG453) Ph2 readout H2 2021 Ph3 start H2 2021 PROS: submission H2 2021 AML Pelacarsen BYL719 (TQJ230) CVRR-Lp(a) TNBC, ovarian cancer, HER2+ TNO155 Solid tumors, multiple aBC, HNSCC 2/3L combinations being explored Branaplam HD: Ph2b start H2 2021 in on-going trials DME: submission H1 2021 (LMI070) Beovu® LXH254 BRAF/NRASm melanoma, RVO, diabetic retinopathy SMA mRAS/RAF NSCLC ‘Wild Cards’ ECF843 (Dry eye: Ph2 readout H2 2021), LNA043 (Osteoarthritis: Ph2b start H1 2021), CSJ117 (Asthma), QBW251 (COPD), NIS793 (Solid tumors) 18 Novartis Q4 and FY 2020 Results | January 26, 2021 | Novartis Media Presentation
Conclusion Delivered on our strategic and operational commitment in 2020 Third successive year of increases in sales, core operating income and margin Progressing the pipeline and key approvals in 2020: Kesimpta® in US, Leqvio®, Zolgensma® in EU, Tabrecta® in US, new indications for Cosentyx® Expecting top and bottom line growth every year through 2025 19 Novartis Q4 and FY 2020 Results | January 26, 2021 | Novartis Media Presentation
Q&A session Vas Narasimhan Susanne Schaffert Chief Executive Officer President, Novartis Oncology Harry Kirsch Richard Saynor Chief Financial Officer CEO, Sandoz Marie-France Tschudin Shannon Thyme Klinger President, Novartis Pharmaceuticals Chief Legal Officer 20 Novartis Q4 and FY 2020 Results | January 26, 2021 | Novartis Media Presentation
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